Effect of 1-year Smoking Cessation in COPD and Asymptomatic Smokers

Smoking is the most important factor causing chronic obstructive pulmonary disease (COPD). It induces lung inflammation, which is thought to play a substantial role in the development and progression of this disease. Smoking cessation is the only treatment that has shown to reduce symptoms and to slow down progression of COPD.

Wim Timens, Brigitte W.M. Willemse (Department of Pathology, University Medical Centre Groningen, The Netherlands) and their team have studied effects of smoking cessation in patients with COPD, compared to smokers without any symptoms. In this longitudinal study the authors particularly focused on the effect on airway inflammation.

Two groups of smokers, 28 with COPD and 25 with normal lung function were included in a one-year smoking cessation programme.

Effects of smoking cessation on airway inflammation were investigated before stopping smoking and one year after successfully quitting, through airway biopsies (small pieces of tissue from the inner part of the airway wall) and sputum samples, coming from the lumen of the central part of the airways.

In the 16 asymptomatic smokers who successfully quit smoking, parameters of inflammation either significantly reduced or did not change. In the 12 successful quitters with COPD however, airway inflammation persisted in airway biopsies at 12 months and several inflammatory parameters even significantly increased. This does not necessarily mean that smoking cessation has no positive effect with respect to treatment of disease. The authors indicate that it is important to realise that inflammation is not only a phenomenon underlying disease development, but that this is also an essential component in repair of the damage associated with disease.

As hardly any tissue damage is present in normal subjects but is considerable in COPD patients, the meaning of persistence or increase of inflammation is not readily clear.

The Dutch team suggests that the observed persistent airway inflammation in patients with COPD is related to repair of tissue damage in the airways.

More detailed research into the further characteristics of the persistent inflammation should elucidate whether this reflects a beneficial or detrimental effect. If the inflammation is still a disease related effect, it can be concluded that smoking cessation has to last longer than one year to show effects, and that perhaps focused anti-inflammatory strategies could be of help and should be developed.

It is also important to realise that when this inflammation represents a beneficial effect, related to convalescence, further measures should not be taken to reduce the inflammation.

Title of the original article:
Effect of 1-year smoking cessation on airway inflammation in COPD and asymptomatic smokers

The European Respiratory Journal is the peer-reviewed scientific publication of the European Respiratory Society (more than 7,500 specialists in lung diseases and respiratory medicine in Europe, the United States and Australia).

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Why do Mosquitoes Bite some People more than others?

Why is it that when you go on vacation some members of your family always seem to get bitten more than others? Scientists at Rothamsted Research in Hertfordshire think they may have found the answer and their work could lead to the development of novel insect repellents.

Research student James Logan has found that some people give off "masking" odours that prevent mosquitoes from finding them. His research builds on earlier studies on cattle, led by Rothamsted's Professor John Pickett, which showed that the number of flies on a herd depended on certain cows being present. The scientists found these key unattractive individuals gave out different chemical signals from the other cows. When these individuals were moved to another field the number of flies afflicting the herd increased.

James, working in collaboration with Professor Jenny Mordue at the University of Aberdeen, tested the behavioural reaction of yellow fever mosquitoes to odour from human volunteers. James said: "The mosquitoes were placed into a y-shaped tube and given the choice of moving upwind down either branch. The air flowing down one branch was laced with odour from the volunteer's hands."

Their results suggest that differential attractiveness is due to compounds in unattractive individuals that switch off attraction either by acting as repellents or by masking the attractant components of human odour. This theory differs from that of other research groups who have suggested that unattractive individuals lack the attractive components. The researchers are now testing these theories further using foil sleeping bags to collect whole body odours from volunteers. James said, "By identifying these key components and understanding how they work we could be closer to new methods of protection from these biting pests that cause losses in livestock and irritation and illness in humans."

James said, "We hope that the work with cattle and mosquitoes will lead to methods of controlling such biting pests that cause losses in livestock and irritation and illness in humans."

Note for editors

1 Rothamsted Research is one of the largest agricultural research institutes in the country and is sponsored by the BBSRC.

2 An article on this research features in the January 2005 issue of Business, the quarterly magazine of the Biotechnology and Biological Sciences Research Council.

3 The original work on Holstein-Frisian heifers was carried out at Rothamsted Research in collaboration with the Danish Institute of Agricultural Sciences and funded by the European Union.

4 The compounds that attracted the mosquitoes were identified using the coupled GC-EAG method. High-resolution gas chromatography is use to split odour extracts into their components parts. These are then passed over the antenna of an insect. Micro-electrodes attached to the antenna detect electrophysiological responses, which indicate that the insect is sensing the compound. Mass spectrometers are then used to identify the compound.

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Light Smoking Triples Lung Cancer And Heart Disease Risk

Smoking just one to four cigarettes a day almost triples a smoker's risk of heart disease and lung cancer, reveals a large study in Tobacco Control.

The impact is stronger for women, the study shows, and quashes the cherished notion that "light" smokers escape the serious health problems faced by heavier smokers.

The researchers tracked the health and death rates of almost 43,000 men and women from the mid 1970s up to 2002. All the participants were aged between 35 and 49 at the start of the study, when they were screened for cardiovascular disease and diabetes.

Although a significant proportion of the light smokers increased their daily consumption, this had not exceeded 9 cigarettes a day. And almost as many had given up as had increased their consumption.

Taking account of risk factors likely to influence the findings, the data nevertheless showed that light smoking endangered health. The steepest risk occurred between nought and four cigarettes a day.

Compared with those who had never smoked, those who smoked between 1 and 5 cigarettes a day were almost three times as likely to die of coronary artery disease.

While there was little difference in the risk of dying from any type of cancer, this was not the case for lung cancer.

Men who were light smokers were almost three times as likely to be killed by lung cancer. And women were almost five times as likely to die of the disease as their non-smoking peers.

Light smokers also had significantly higher death rates from all causes - 1.5 times - than those who had never smoked, with the death rates corresponding to the number of cigarettes smoked every day.

As the light smokers had smoked for fewer years than the heavy smokers, the researchers analysed the projected impact of smoking at this level for five years.

This indicated that the risk of death from coronary artery disease would have been 7% higher, and the risk of lung cancer would have been 47% higher in women.

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New MRSA Bacteria Killer Registered by EPA

The EPA (Environmental Protection Agency) has recently registered a new product for preventing and eliminating methicillin-resistant Staphylococcus aureus (MRSA), which causes potentially deadly infections commonly known as "staph" infections. The MRSA "super bug" is typically contracted in hospitals, in other healthcare environments, and in health clubs and locker rooms.

The EPA has registered Selectrocide� chlorine dioxide for use as a disinfectant on hard, non-porous surfaces and instruments, including those used within hospitals and other medical settings. As a no-wipe, no-rinse spray, Selectrocide chlorine dioxide can also be used on hard, non-porous surfaces in health clubs, spas, public places and swimming facilities as a treatment against MRSA. The EPA has also registered Selectrocide� as a disinfectant for vancomycin-resistant Enterococcus faecalis, athlete's foot, Mycobacterium bovis (TB) and other pathogens that spread in many environments.

MRSA is usually spread by direct physical contact with those already infected or through indirect contact by touching objects (towels, clothes, sports equipment, etc.) that infected skin has contaminated. Consequently, any heavily trafficked area can be a source of infection.

According to a report by the BBC News, "Staphylococcus aureus is the leading cause of human infections in the skin and soft tissues, bones and joints, abscesses and normal heart valves. It flourishes in the hospital setting, producing bloodstream and surgical wound infections, including MRSA." (news.bbc.co.uk/1/hi/health/4671585.stm)

HOW SELECTROCIDE� KILLS MRSA AND OTHER DEADLY PATHOGENS

Selectrocide� is greater than 99% pure chlorine dioxide, an ideal biocide because of its ability to kill viruses, bacteria, fungi, and algae at low saturation levels (parts per million) in a manner that does not allow pathogens to build resistance to the compound.

Prior to Selectrocide�, healthcare and health club environments were limited to using substances like bleach and quaternary ammonium compounds that can leave residue and require higher concentrations than does chlorine dioxide to achieve the same antimicrobial efficacy.

Selectrocide's chlorine dioxide is produced in water and sprayed, mopped, or sponged onto surfaces that require disinfection. After application, the solution is left on target surfaces and does not require rinsing. Due to the comparatively low application concentrations required to kill pathogens, Selectrocide is compatible with most materials.

THE DEVELOPMENT OF MRSA AND ITS INCREASING RESISTANCE TO ANTIBIOTICS

Staphylococcus aureus (SA)-Antibiotic Resistance (General): Throughout history, Staphylococcus aureus (SA) has been a dangerous pathogen once it has successfully breached the normal defense system. The first effective antibiotic against SA, penicillin, became available in the 1940s. Soon after, SA evolved resistance to penicillin, and by the late 1950s, 50 percent of all SA strains were resistant. Today, fewer than 10 percent of SA infections can be cured with penicillin. The next weapons against SA, methicillin and cephalosporin, became available in the 1960s and 1970s. By the late 1970s, some strains of SA had evolved resistance to these drugs. Today, as many as 50 percent of SA strains isolated from U.S. hospitals are resistant to methicillin. (Source: National Institutes of Health)

GENERAL BACKGROUND INFORMATION ON CHLORINE DIOXIDE AND SELECTROCIDE�

Chlorine dioxide is effective at low concentrations across a wide range of pH (roughly 4 to 9), and, because it is a gas in its natural state, dissipates upon exposure to sunlight As a consequence, it is known widely as one of the most effective inhibitors of algae, yeast, mold, fungi and viruses. However, because transporting the gas is prohibited in all but frozen forms, pure chlorine dioxide has heretofore been limited to use in large concerns that employ chemical generators, such as pulp mills (controlling slime) and municipal water systems (water purification applications).

Similarly, in cleaning and antimicrobial knockdown applications, pure chlorine dioxide has been unavailable, and only with "stabilized" solutions or acidified sodium chlorite, which are corrosive and produce significant chemical residues, could any of the advantages of chlorine dioxide be realized.

JUST ADD WATER -- AND WAIT. Now, Selectrocide� brings the power of greater than 99% pure chlorine dioxide solutions to point-of-use applications. Selectrocide� produces chlorine dioxide simply by submersing the product in water. The resulting chlorine dioxide solution can be used to kill disease-bearing bacteria, yeasts, molds, fungi and algae using spraying, washing or "dip" cleaning methods.

Selectrocide� makes it possible-for the first time-to generate specific concentrations of chlorine dioxide at the point of use, at neutral pH and with very low residuals, using only tap water.

SUMMARY OF SELECTROCIDE� BENEFITS

* US EPA-registered as a disinfectant against MRSA, and other potentially virulent pathogens.
* Pathogens cannot build up resistance to Selectrocide� because it kills harmful organisms by breaking down cell walls.
* Easy to use and does not require HAZMAT or complicated equipment
* Can be made on-site in specific quantities and in concentrations desired. Only tap water is required to generate the chlorine dioxide.
* Because it kills pathogens with such efficacy, Selectrocide� may reduce costs because fewer disinfection treatments may be required during a given maintenance and cleaning cycle.

Further information is available at http://www.selectivemicro.com or by calling 978-927-6610 X20.

ABOUT SELECTIVE MICRO TECHNOLOGIES

Formed in 1999, Selective Micro Technologies is a private company based in Beverly, Massachusetts. Combining sophisticated science with innovative product design, Selective Micro has invented a proprietary delivery system that controls the rate and efficiency of gas-producing reactions. The competitive advantage of Selective Micro's products is their ability to generate specific concentrations of greater than 99% pure chlorine dioxide at neutral pH for point-of-use operators, using only tap water, without capital equipment. The Company holds two US patents, and has several other patent applications pending in the US and abroad.

Selective Micro and logos are registered trademarks of Selective Micro Technologies, LLC. Selectrocide� is a trademark of Selective Micro Technologies, LLC. � 2005 Selective Micro Technologies. All Rights Reserved.

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Does vitamin C Help Prevent or Treat the Common Cold? Maybe Not

Linus Pauling's book VITAMIN C AND THE COMMON COLD, published in 1970, was a bestseller and led many people to believe in the value of the vitamin for cold prevention and treatment. But an article in this month's PLoS Medicine reviewing all of the best clinical research on this topic, suggests that the public's enthusiasm for the vitamin may be unjustified.

Robert M Douglas of the Australian National University, Canberra, and Harri Hemil� of the University of Helsinki, Finland, reviewed the best quality studies on vitamin C and the common cold done over the last 65 years. All of these studies compared a daily dose of 200mg of vitamin C or more against a dummy pill (placebo).

Did vitamin C given for prevention reduce the risk of picking up a cold? The authors looked at 23 studies done in the general population, using doses of up to 2g daily, and found that vitamin C did not reduce the risk. They conclude that "the lack of effect of prophylactic vitamin C supplementation on the incidence of common cold in normal populations throws doubt on the utility of this wide practice."

In these prevention studies, those people who were given vitamin C and then caught a cold experienced a small reduction in the duration of the cold compared with those taking a placebo. The authors say that the clinical significance of this minor reduction "is questionable, although the consistency of these findings points to a genuine biological effect."

But the authors did find evidence that the vitamin could help prevent colds in people exposed to extreme physical exertion or cold weather. They found six studies in which the vitamin or a placebo was given to marathon runners, skiers and soldiers exposed to significant cold and/or physical stress. Those taking the vitamin experienced, on average, a 50% reduction in common cold incidence. The authors urge "great caution", though, in making generalizations from this finding in 6 studies that is mainly based on marathon runners.

What about vitamin C as a possible treatment for an established cold? The authors found seven trials (all in adults) evaluating whether vitamin C taken when their symptoms started would shorten the cold. When they looked at all seven studies together, they found no benefit from taking the vitamin. But in one of the seven trials, patients took a single very high dose of the vitamin (8 g) on the day their symptoms started and experienced a shorter illness compared with people who took a placebo pill. (3) The authors say that the results in this single trial are "tantalising and deserve further assessment."

Douglas and Hemil�'s article summarizes their more detailed review of the evidence that is published by the Cochrane Library (see http://www.cochrane.org) and that is freely available via the PLoS Medicine website.

Citation: Douglas RM, Hemilia H (2005) Vitamin C for preventing and treating the common cold. PLoS Med 2(6): e168.

All works published in PLoS Medicine are open access. Everything is immediately available without cost to anyone, anywhere--to read, download, redistribute, include in databases, and otherwise use--subject only to the condition that the original authorship is properly attributed. Copyright is retained by the authors. The Public Library of Science uses the Creative Commons Attribution License.

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ADHD - FDA expands indication for ADDERALL XR(R) (CII) confirming safety and efficacy in adolescents

Shire Pharmaceuticals Group plc announced today that the US Food and Drug Administration (FDA) has approved ADDERALL XR(R) (mixed salts of a single-entity amphetamine product) as a once-daily treatment for adolescents aged 13 to 17 with attention deficit hyperactivity disorder (ADHD). Since October 2001, ADDERALL XR has been approved in the U.S. for treatment in children aged 6 to 12 years and since August 2004 in adults 18 years and older. ADDERALL XR is currently the most commonly prescribed brand of ADHD medication in the United States.

"There has long been an unmet need for ADHD research and treatment among the adolescent population despite an increasing awareness of ADHD's potential impact on quality of life. Therefore, approval of an ADHD treatment for this underidentified age group is an important milestone," explained Dr. Timothy Wilens of Massachusetts General Hospital. "The symptoms of ADHD often continue past childhood into adolescence and adulthood, where they can have a significant impact on an individual's family, academic performance, and overall quality of life. Stimulant therapies are effective and generally well tolerated, and have been used medically in patients for more than 60 years."

ADHD affects approximately 3 to 7 percent of all school-age children, or approximately two million U.S. children, and is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. ADHD can have a profound effect on a child's quality of life and can be serious enough to interfere beyond academics, leading to problems maintaining friendships, difficulties focusing on sports or other after-school activities, and challenges in relating well with other family members. Untreated ADHD has long-term adverse effects on academic performance, vocational success and social-emotional development. Evidence also suggests that many with untreated ADHD may be at risk for other problems, such as drug abuse, anti-social behavior and poor self-esteem. As they age, up to 65 percent of adolescents with ADHD may still exhibit symptoms into adulthood.

"The new adolescent labeling for ADDERALL XR offers health care providers, parents and patients continuity in the management of ADHD symptoms as children become older," said Greg Flexter, Executive Vice President and General Manager, Shire North America. " We are pleased that a thorough review by the FDA once again confirms the safety and efficacy of Adderall XR in another age group."

The FDA based its approval on data that Shire provided in a supplement to its New Drug Application (sNDA). These data included the results of a pharmacokinetic study and a placebo-controlled, fixed-dose clinical trial of a range of doses of once-daily ADDERALL XR in adolescents with ADHD.


In a randomized, double-blind, placebo-controlled clinical trial, ADDERALL XR was proven to be significantly more effective than placebo in the treatment of ADHD symptoms in adolescents. ADDERALL XR was generally safe and well tolerated with adverse events similar to those seen in other populations. The most common adverse events were loss of appetite, insomnia, abdominal pain, and weight loss. The results of this study show that ADDERALL XR produces a positive clinical response in adolescents diagnosed with ADHD. The study showed ADDERALL XR at doses between 10 mg and 40 mg daily were statistically significantly superior to placebo (p<0.0001) on the ADHD-RS-IV (investigator-rated with the parent and adolescent). Furthermore, 63 percent of investigators considered their subjects' ADHD symptoms to be much improved or very much improved with ADDERALL XR compared to 27 percent for placebo (p<0.0001).

About ADDERALL XR

ADDERALL XR may not be right for everyone. ADDERALL XR was generally well tolerated in clinical studies. The most common adverse events in pediatric trials included loss of appetite, insomnia, abdominal pain, and emotional lability. The most common side effects in the adolescent trial included loss of appetite, insomnia, abdominal pain, and weight loss. The most common adverse events in the adult trial included dry mouth, loss of appetite, insomnia, headache, and weight loss.

The effectiveness of ADDERALL XR for long-term use has not been systematically evaluated in controlled trials. As with other psychostimulants indicated for ADHD, there is a potential for exacerbating motor and phonic tics and Tourette's syndrome. A side effect seen with the amphetamine class is psychosis. Caution also should be exercised in patients with a history of psychosis.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. ADDERALL XR generally should not be used in children or adults with structural cardiac abnormalities. ADDERALL XR is contraindicated in patients with symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism and glaucoma, known hypersensitivity to this class of compounds, agitated states, history of drug abuse, or current or recent use of MAO inhibitors. ADDERALL XR should be prescribed with close physician supervision.

About ADHD

ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity more frequent and severe than typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; at least six of nine symptoms of hyperactivity/impulsivity; the onset of such symptoms before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); and that the symptoms continue for at least six months.

Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.

For further information please contact: Media
Marion Glick (Porter Novelli), 212-601-8273
Janice Miller (Porter Novelli), 212-601-8176

Shire Pharmaceuticals Group plc

Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on ADDERALL XR, please visit the ADDERALL XR website at http://www.AdderallXR.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to Health Canada's suspension of ADDERALL XR(R) sales in Canada and the expected product approval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerative colitis), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Agency in the United States, Shire's ability to consummate and benefit from its proposed acquisition of Transkaryotic Therapies, Inc., Shire's ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.

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Execution by Lethal Injection Is Not Humane or Painless

Prisoners executed by lethal injection in the US may have experienced awareness and unnecessary suffering because they were not properly sedated, concluded a research letter in last week's issue of The Lancet. The authors believe the use of lethal injection should cease in order to prevent unnecessary cruelty and a public review into anaesthesia procedures during executions is necessary.

Lethal injection is the most common way people are legally put to death in the USA. It has eclipsed all other methods of execution because of public perception that the process is relatively humane and does not violate the US Constitution's Eight Amendment prohibiting cruel and unusual punishment. Anaesthesia during lethal injection is essential to minimise suffering and preserve public opinion that lethal injection is a near-painless death. Lethal injection generally consists of the sequential administration of sodium thiopental for anaesthesia, pancuronium bromide to induce paralysis, and finally potassium chloride to stop the heart and cause death. Without anaesthesia the person would experience suffocation and excruciating pain without being able to move.

Leonidas Koniaris (University of Miami Miller School of Medicine, USA) and colleagues analysed protocol information from the states of Texas and Virginia, where around 45% of executions are done. They found that executioners-typically one to three emergency medical technicians or medical corpsmen*-had no training in anaesthesia, drugs were administered remotely with no monitoring of anaesthesia and there were no data collection, documentation of anaesthesia, or post-procedure peer review. They also noted that neither state had a record of the creation of its protocol. The investigators also analysed data from autopsy toxicology reports from 49 executions in Arizona, Georgia, North Carolina, and South Carolina. They found that concentrations of thiopental in the blood were lower than that required for surgery in 43 of the 49 executions; 21 inmates had concentrations consistent with awareness. The study suggests that the current practice of lethal injection for execution fails to even meet veterinary standards for putting down animals.

Dr Koniaris states: "Our data suggest that anaesthesia methods in lethal injection in the US are flawed. Failures in protocol design, implementation, monitoring and review might have led to unnecessary suffering of at least some of those executed. Because participation of doctors in protocol design or execution is ethically prohibited, adequate anaesthesia cannot be certain. Therefore to prevent unnecessary cruelty and suffering, cessation and public review of lethal injection is warranted."

In an accompanying Editorial The Lancet comments: "Whether you receive the death penalty depends not on what you have done, but where you committed your crime, what colour your skin is, and how much money you have. The use of the death penalty not only varies from state to state (12 US states have no death penalty) but from jurisdiction to jurisdiction within a state. Repeated studies have shown a pattern of racial discrimination in the administration of the death penalty.

"Capital punishment is not only an atrocity, but also a stain on the record of the world's most powerful democracy. Doctors should not be in the job of killing. Those who do participate in this barbaric act are shameful examples of how a profession has allowed its values to be corrupted by state violence."

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Denosumab, Shows Increased Bone Mineral Density, Amgen

Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced that twice-yearly subcutaneous injections of denosumab (60 mg), (previously referred to as AMG 162), increased bone mineral density (BMD) in the lumbar spine, total hip, distal 1/3 radius and total body compared to placebo at 24 months. The study also included an open label Fosamax�* (alendronate) arm. Investigators reported on a pre-planned exploratory analysis at the American College of Rheumatology Annual Scientific Meeting in San Diego, California.

The ongoing, multi-center, phase 2 dose-ranging trial includes results from 337 healthy postmenopausal women with low BMD who completed two years of study. Researchers reported denosumab 60mg increased BMD of the lumbar spine by 7.4 percent in women administered the therapy twice yearly and 6.2 percent for Fosamax� 70mg weekly. Across all doses and dosing intervals, denosumab increased the BMD of the lumbar spine by 4.3 to 9.0 percent over baseline.

"The two-year results showed the continued effect of denosumab in increasing bone mineral density in postmenopausal patients with low bone mass," said Michael Lewiecki, MD, clinical assistant professor of medicine, University of New Mexico School of Medicine, Albuquerque, NM. "These data suggest denosumab, when administered twice a year, may offer a promising alternative for the prevention and treatment of osteoporosis."

Denosumab is designed to target RANK Ligand, a protein that acts as the primary signal to promote bone removal. In many bone loss conditions, RANK Ligand overwhelms the body's natural defense against bone destruction.

Preclinical models have demonstrated that inhibiting RANK Ligand leads to significant improvements in cortical and trabecular bone density, volume and strength.

Denosumab is currently being studied for its potential in a broad range of bone loss conditions including osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma and rheumatoid arthritis.

"Because denosumab targets RANK Ligand, it functions in a way that is entirely different than other bone loss treatments," said Willard Dere, MD, senior vice president of global development and chief medical officer, Amgen. "We believe its unique, targeted approach to regulating bone loss may have the ability to transform how we treat these conditions."

Researchers also reported twice-yearly injections of denosumab (60 mg) increased total hip BMD by 5.1 percent after 24 months. Fosamax� 70 mg weekly produced a 3.4 percent increase during the same time period. Denosumab, at all doses and dosing intervals studied, increased total hip BMD from 2.8 to 5.1 percent. Across all doses and dosing intervals, distal 1/3 radius BMD increased from 0.6 to 2.5 percent, and total body BMD increased from 0.9 to 4.5 percent.


Occurrence of adverse events was similar among the denosumab, placebo, and Fosamax� groups and showed no new pattern of events in the second year of treatment. No neutralizing antibodies to denosumab were observed throughout the two years.

Denosumab (AMG 162) Study Design

Investigators randomized 412 postmenopausal women, average age 63, with low BMD to receive denosumab, placebo or Fosamax�. The purpose of the study was to determine the safety and efficacy of denosumab on lumbar spine BMD compared with placebo at 12 months. The doses of denosumab evaluated included 6, 14 or 30 mg every three months or 14, 60, 100 or 210 mg every six months. The researchers administered all doses of denosumab via subcutaneous injection. Patients receiving Fosamax� followed the approved indication and oral dosing instructions of 70 mg once weekly.

At entry, the women averaged -2.1 on their T-scores, a densitometric rating of BMD in which scores between -1.0 and -2.5 indicate osteopenia (thinning bone) and below -2.5 indicate osteoporosis, according to the World Health Organization (WHO).

The Need for Bone Loss Treatments

Osteoporosis

Bone loss represents a significant clinical and economic burden. Osteoporosis is a major public health threat for an estimated 44 million Americans, or 55 percent of the people 50 years of age and older. In the U.S. today, 10 million individuals are estimated to already have the disease and almost 34 million more are estimated to have low bone mass, placing them at increased risk for osteoporosis.

Of the 10 million Americans estimated to have osteoporosis, eight million are women and two million are men. In addition, one in two women and one in four men over age 50 will have an osteoporosis-related fracture in their remaining lifetime.

In Europe, recent estimates have stated that approximately 3.8 million people have experienced bone fractures related to osteoporosis.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com.

Forward-Looking Statement

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly or sometimes even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, sales of our products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products.

In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products.

Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

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New Acne Treatment - Anti-DHT Clearogen

Almost 90% of young people age 12-24 suffer from acne as well as over 50% of adult women, which is reflected in the over-flowing acne treatment aisles of drug stores. Incredibly, none of these treatments get to the root of the problem.

Clearogen is the first professional over-the-counter product based on prescription grade ingredients and scientifically proven natural botanicals to clear existing acne and prevent new acne at the first step of its formation� and it works. Formulated by Board Certified Dermatologist Alex Khadavi, Clearogen works at the root cause of acne.

What Causes Acne?

Acne is caused by an excessive amount of oil secreted through the oil glands. Normally these glands produce adequate amounts of oils that keep our skin healthy, shiny and young. In the presence of a body hormone known as DHT (Dihydro Testosterone), however, these glands produce excessive amounts of oil resulting in the formation of acne. DHT is a hormone by-product produced by both males and females particularly during puberty. As the levels of DHT increase, the oil glands become overly stimulated and result in overproduction of oil. This excessive oil accumulates in the pores and clogs the pores, resulting in acne.

What makes Clearogen Different?

This one-of-a-kind treatment, developed by Dr. Alex Khadavi after years of research, clears existing acne and prevents new acne by STOPPING THE FIRST STEP OF ACNE DEVELOPMENT. This is accomplished through reducing DHT production to eliminate the cause of excessive oil production by the oil glands at the hormonal level.

Scientifically Speaking

1. Clearogen inhibits the conversion of Testosterone to DHT and reduces the cause of excessive oil production.

2. Clearogen blocks the Androgen Receptors and prevents the stimulation of oil glands by DHT.

3. Clearogen opens the pores, kills bacteria and reduces inflammation, allowing healing and skin renewal for clear and vibrant skin.

Clearogen is the only product to use natural botanicals that work to dramatically reduce DHT resulting in normal oil production. As such acne can be prevented at the root.

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Cannabis-based drugs could offer New Hope for Inflammatory Bowel Disease Patients

Researchers investigating anecdotal evidence that cannabis relieves some of the symptoms of inflammatory bowel disease (IBD) have discovered a potential new target for cannabis-derived drugs for treatment of the disease.

This finding, published in the journal Gastroenterology, could bring new hope for the UK's 90,000 - 180,000 sufferers of diseases like Crohn's and ulcerative colitis1 with the possibility that cannabis-derived drugs may help to heal the gut lining, which is damaged during the course of disease.

Both Crohn's and ulcerative colitis - often referred to under the umbrella term of IBD - cause patients' immune systems to go into overdrive, producing inflammation in different areas of the gastrointestinal tract.

This inflammation can cause pain, urgent diarrhoea, severe tiredness and loss of weight, and is most commonly diagnosed in young adults of both sexes between the ages of 15 and 25.

Patients with IBD who are also users of cannabis often report that their symptoms are alleviated following cannabis use, suggesting that the gut is able to respond to some of the molecules found in cannabis.

Investigating this phenomenon, researchers from the University of Bath worked with colleagues at the Royal United Hospital in Bath to look at the interaction of cannabis with specific molecules, known as receptors, found on the surface of cells in the gut.

Examining gut samples from healthy people and IBD patients, the researchers looked at two specific receptors, called CB1 and CB2, which are known to be activated by the presence of molecules found in cannabis.

They discovered that whilst CB1 is present in healthy people, the presence of CB2 increases in IBD patients as their disease progresses.

The researchers believe that the presence of CB2 receptor only during the disease-state may be linked to its known role in suppression of the immune system. In other words, it is part of the body's natural mechanisms that attempt to restore the normal healthy state of the gut.

If so, this makes it an ideal candidate for the development of new cannabis-derived drugs to help IBD patients. They also found that the CB1 receptor helps to promote wound healing in the lining of the gut.

"This gives us the first evidence that very selective cannabis-derived treatments may be useful as future therapeutic strategies in the treatment of Crohn's and ulcerative colitis," said Dr Karen Wright from the University's Department of Pharmacy and Pharmacology.

"This is because some extracts from cannabis, known as cannabinoids, closely resemble molecules that occur naturally in our body, and by developing treatments that target this system, we can help the body recover from some of the effects of these diseases."


Ordinarily, CB1 and CB2 have the task of recognising and binding to a family of substances called "endocannabinoids" that occur naturally in our bodies. Once these receptors have detected the presence of specific molecules in their surrounding environment, a chain of biochemical signals is activated which culminates in switching immune responses on or off - depending on what their function is.

"The normal job of the CB1 and CB2 receptors is to help moderate diverse responses throughout the body, but their presence in the gut means that they could be useful targets for the development of cannabis-derived drugs for controlling the progression of IBD," said Dr Wright.

"The research shows that whilst cannabis use may have some benefits for patients with IBD, the psychoactive effects and the legal implications associated with herbal cannabis use make it unsuitable as a treatment. Targeting drug development to components of the in-built cannabinoid system could be the way forward."

Cannabis-based medicines that help alleviate the pain endured by Multiple Sclerosis patients have already been given a licence for use in Canada, and Salisbury-based GW Pharmaceuticals is pioneering many of the advances in this field.

The research was funded by the Wellcome Trust and an NHS Research Grant.

Case studies of people with colitis or Crohn's are available from National Association for Colitis and Crohn's Disease on +44 (0)1727 830038.

1Figures from the National Association for Colitis and Crohn's Disease. There is no national database of people with Crohn's or Colitis - the figures are taken from estimates published by the British Society for Gastroenterology in 2004.

Inflammatory Bowel Disease

� Inflammatory Bowel Disease (IBD) is an umbrella term referring to two chronic diseases that cause inflammation of the intestines: ulcerative colitis (UC) and Crohn's disease (CD).

Crohn's disease

� Between 30,000 and 60,000 people in the UK live with CD. Between 3,000 and 6,000 new cases are diagnosed each year.

� In 1996, a study from South Glamorgan reported a doubling of the number of children diagnosed with CD between 1983 and 1993

� In 1999 a study of children in Scotland has reported a 50% increase over 10 years in the incidence of CD.

� CD can affect anywhere from the mouth to the rectum but most commonly affects the small intestine.

� It causes inflammation, deep ulcers and scarring to the wall of the intestine and often occurs in patches with healthy tissue in between. There is no cure for CD at present.

� The main symptoms are pain, urgent diarrhoea, severe tiredness and loss of weight.

� CD is quite often associated with other inflammatory conditions affecting the joints, skin and eyes. Most patients will be treated with drugs, including steroids, to reduce inflammation or by means of special liquid feeds to rest the bowel. Surgery may be required to remove narrowed or damaged parts of the intestine.

� The condition is named after Dr Burril Crohn, one of the three doctors who first identified the disease in 1932. � The cause of CD has not yet been identified.

Ulcerative Colitis

� Between 60,000 and 120,000 people in the United Kingdom live with UC

� Between 6,000 and 12,000 new cases are diagnosed each year.

� Ulcerative Colitis affects men and women equally.

� The number of new cases each year has not risen recently, but is not decreasing.

� Ulcerative Colitis affects the colon (large intestine) or rectum. Inflammation and ulcers develop on the inside lining of the colon resulting in pain, urgent and bloody diarrhoea, and continual tiredness.

� There is no cure for Ulcerative Colitis at present.

� The condition varies as to how much of the colon is affected and the severity of the symptoms also fluctuates unpredictably over time. Patients are likely to experience flare-ups in between intervals of reduced symptoms or remission.

� Most patients will be treated with drugs, including steroids, to control or reduce the inflammation. Some people need surgery to remove the affected part of the colon, if their symptoms do not respond to treatment with drugs.

� The cause of UC has not yet been identified. The University of Bath is one of the UK's leading universities, with an international reputation for quality research and teaching. In 17 subject areas the University of Bath is rated in the top ten in the country.

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Rheumatoid Arthritis, cannabis Based Medicine Eases Pain and Suppresses Disease

The first study to use a cannabis-based medicine (CBM) for treating rheumatoid arthritis has found that it has a significant effect on easing pain and on suppressing the disease.

Writing in the medical journal Rheumatology [1], the researchers say that although the differences were small and variable in the group of 56 patients they studied, the results are statistically significant and a larger trial is needed to investigate in more detail the effects of CBM on the disease which affects approximately 600,000 people in the UK (1 in 100 of the population).[2]

There is anecdotal evidence that cannabis can provide pain relief for people with rheumatoid arthritis (RA), and in a recent survey 155 (16%) of 947 people who obtained cannabis on the black market for medicinal reasons said they did so to obtain relief from symptoms of RA. However, this study in Rheumatology journal, led by David Blake, Professor of Bone and Joint Medicine at the Royal National Hospital for Rheumatic Diseases (RNHRD), Bath, and the University of Bath, UK, is the first randomised controlled trial to investigate the effect of a CBM on RA. It is published online today (Wednesday 9 November).

In the double-blind trial, the researchers randomised 31 patients to receive the CBM and 27 the placebo. The CBM (brand name: Sativex) was in the form of an easy-to-use mouth spray that patients could administer themselves up to a maximum of six doses a day. The CBM consisted of a blend of whole plant extracts, standardised for content, that delivered approximately equal amounts of two key therapeutic constituents from the cannabis plant: delta-9-Tetrahydrocannabinol (THC) and cannabidiol (CBD). Mouse studies have shown that THC and CBD have anti-inflammatory effects, and that CBD blocked progression of RA and produced improvements in symptoms.

Dr Ronald Jubb, Consultant Rheumatologist, at the University Hospital Birmingham NHS Foundation Trust, UK, said: "Patients had a baseline assessment at the beginning of the trial and then were randomised to receive either the CBM or placebo. Patients only took the doses in the evening in order to minimise possible intoxication-type reactions. The starting dose was one actuation within half an hour of retiring, and this was increased by one actuation every two days to a maximum of six doses according to individual response over a period of two weeks. Stable dosing was then maintained for a further three weeks."

The researchers found that in comparison with the placebo, patients who had taken the CBM had statistically significant improvements in pain on movement, pain at rest, quality of sleep, inflammation (measured by a Disease Activity Score involving 28 joints - DAS 28) and intensity of pain (measured by the Short-Form McGill Pain Questionnaire SF-MPQ).

For instance, on a score of 0-10 where 0 is no pain, CBM patients on average moved from 7 to 4.8 for pain on movement (placebo patients moved from 6.7 to 5.3), 5.3 to 3.1 (placebo 5.3 to 4.1) for pain at rest, and 5.7 to 3.4 (placebo 5.8 to 4.6) for quality of sleep. On the DAS 28 score of 0-10, the CBM patients moved from 5.9 to 5 (placebo 6 to 5.9), and on the SF-MPQ score of 0-100 for intensity of pain at present, the CBM patients moved from 48 to 33, while the placebo patients remained unchanged at 50.


Adverse side effects were mostly mild or moderate (e.g. dizziness, light-headedness, dry mouth, nausea). Of the eight patients who experienced mild dizziness, in four patients this occurred during the initial two-week period when they were gradually increasing the doses, and two occurred two days after this initial period, so these were probably due to patients getting used to the correct dose. No patients taking the CBM had to withdraw from the trial due to adverse side effects, but three did from the placebo group.

Dr Philip Robson, Senior Research Fellow and Consultant Psychiatrist at the Oxford University Department of Psychiatry and Director of the Cannabinoid Research Institute within GW Pharmaceuticals (the manufacturer of Sativex), explained: "Withdrawals from the placebo group were probably due to a psychological effect, a spontaneous occurrence, or a reaction with another medicine."

Dr Jubb said: "The results from the first controlled study of CBM in rheumatoid arthritis are encouraging, with overall improvements in pain on movement and at rest, improvement in the quality of sleep and improvement in the overall condition of the patients' arthritis. Whilst the differences are small and variable across the patient group, they represent benefits of clinical relevance and indicate the need for more detailed investigation through larger trials to see exactly where CBM could be best used with minimum side effects."

If further trials are run, researchers will probably extend the dosing period over the full 24-hour period. Dr Robson said: "The beneficial effects in this study occurred in the context of a dosing regime restricted to evening dosing in order to minimise any possible intoxication-type reactions. However, 24-hour dosing with Sativex, using a self-titration regime, in trials for multiple sclerosis resulted in only minimal intoxication scores."

He continued: "The element that can cause the 'high' in cannabis - THC - also has valuable pharmacological activity. It is thought to be an essential therapeutic component and therefore it can't be removed from the medicine. However, the method of giving the doses, via the mouth spray, and the principle of self-titration, where each patient gradually determined their own optimal dose level up to a maximum of six doses a day, minimised the risk of intoxication."

Dr Robson said that fears that the CBM could be abused by patients hoping to get a "high" were probably unfounded. "It seems that in practice this is a very rare event. More than 1,000-patient years of treatment with Sativex in clinical trials have been accumulated and to date there has not been a single documented case of abuse. The fact is that the motivation of medicinal users of cannabis-based medicine is entirely different from recreational users: the former simply want symptom relief and the ability to go about their normal lives, and for them intoxication would be a distinct disadvantage; for the latter, smoking marijuana is infinitely more intoxicating than Sativex and is still easily available."

[1] Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Rheumatology Advance Access published on November 9, 2005.
doi:10.1093/rheumatology/kei183

[2] Rheumatoid arthritis affects three times as many women as men. Prevalence in the UK is approximately 0.5% in men and 1.8% in women, increasing after the age of 64 to 2% in men and 5% in women. There are many more people with less severe forms of RA that do not meet the diagnostic criteria for definite or classical disease.

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Vitamin C Foundation to Offer Best Vitamin C

The Vitamin C Foundation asserts that contrary to marketing claims, one form of vitamin C is best taken by mouth. Individuals may now purchase superior vitamin C from the not-for-profit Vitamin C Foundation. Proceeds from sales fund vitamin C research.

Houston, Texas - Vitamin C is the most popular nutritional supplement and there has been debate as to which form of vitamin C is best, and in some quarters, there is debate regarding what constitutes "real" vitamin C. One form, L-ascorbic acid, is the most biologically active form of the vitamin. The Vitamin C Foundation believes that ascorbic acid is superior to other forms and it has begun selling it as a powder from its web site http://www.vitamincfoundation.org

People are often confused about vitamin C. According to Foundation co-founder, Dr. Owen R. Fonorow, Ph.D., "We've posted science articles about vitamin C for the past eight years. There are a variety of vitamin C products on the market, and people frequently request our recommendation for an ideal form of the vitamin. We believe it best to recommend a product over which we have quality control. Our vitamin C is a pure powder that is produced to our specifications in a top domestic laboratory. Proceeds from sales will help us to fund our web site and independent research."

Most animal species produce ascorbic acid molecules in the liver or kidney from the sugar glucose; human beings have lost this ability. Experts, such as the late Linus Pauling, Ph.D., recommend taking vitamin C orally as ascorbic acid, perhaps buffered with some added bicarbonate of soda.

One of the world's leading Vitamin C experts, Robert Cathcart, MD (orthomed.com) commends other forms of vitamin C as "fine products," the mineral ascorbates, calcium-ascorbate or magnesium-ascorbate. However, Dr. Cathcart has not been able to achieve the so-called "ascorbate effect" with mineral ascorbate forms of the vitamin. Cathcart reports that in his practice, now spanning 20 years and more than 20,000 patients, only ascorbic acid by mouth can achieve the results that he achieves with intravenous vitamin C.

The much advertised Ester-C(tm) is a patented form of calcium ascorbate.

The ascorbate effect, explains Dr. Cathcart, is the ability of vitamin C at very high dosages to quench numerous free radicals. Cathcart likens this effect in his patients to pouring water on a "free radical" fire. He explains that each molecule of ascorbic acid reacts with two free electrons or "free radicals." Mineral ascorbates, already bound to the mineral ion, react only with one free radical per molecule. This means, literally, that twice as much vitamin C in the form of mineral ascorbates is necessary for positive therapeutic results.

Pharmacologists have determined that ascorbic acid can be absorbed and pass directly into the blood stream through the stomach lining. This absorption short-cut means the vitamin does not have to travel into the intestines.

Ascorbic acid should not be used intravenously (IV) "as is," according to Dr. Cathcart; only sodium-ascorbate is suitable IV.

The Vitamin C Foundation's Vitamin C Powder is pure ascorbic acid: Its hypoallergenic and is certified 100% free of corn and free of Genetically Modified Organisms (GMO-Free). There are no additives, fillers or binders. The product is to be taken orally (rather than intravenously) and can be mixed with water or juice. It can also be added to drink-mix formulas, such as the Foundation's new Cardio-C vitamin C/lysine drink mix, or the Tower Laboratories HeartTechnology, a more complete Pauling Therapy drink mix.

The Vitamin C Foundation is a Texas nonprofit organization that has qualified for 501 (c )(3) status by the IRS. When ordering vitamin C from the Foundation customers have the option of making a contribution to the Foundation, which may be tax deductible and which support the Foundation's work and independent vitamin C research.

For more information regarding this subject, or to schedule an interview with Owen Fonorow, please call Mike Till at 281/443-3634 or e-mail Mike at e-mail protected from spam bots.

The Vitamin C Foundation is a USA nonprofit, charitable organization that has been assigned the IRS tax-exempt 501(c)(3) designation as a Texas non-profit corporation devoted to preserving the "lost knowledge" of ascorbic acid and its essential role in life. Technical advisors include Drs. A. Hoffer, MD, PhD,. Steve Hickey, PhD, Hilary Roberts, PhD, Robert Cathcart III, MD, Thomas Levy, MD, JD, and John Ely, PhD, The Foundation is dedicated to the memory of Linus C. Pauling.

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TV has negative impact on very young children's learning abilities

Television viewing before the age of three may have adverse effects on subsequent cognitive development, according to a study in the July issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.

Three- to five-year-old children watch an average of two or more hours of television or videos per day and much of this is not children's educational programming, according to background information in the article. Fifty-nine percent of children younger than two years regularly watch an average of 1.3 hours of television per day, despite the fact that there is no programming of proven educational value for children this young. A substantial portion of television actually watched by children does not meet the American Academy of Pediatrics recommendation of no screen time for children younger than two and only high quality, age-appropriate viewing thereafter, the authors suggest.

Frederick J. Zimmerman, Ph.D., and Dimitri A Christakis, M.D., M.P.H., of the University of Washington, Seattle, analyzed data from The National Longitudinal Survey of Youth 1979 Children and Young Adults (NLSY-Child), begun in 1986 and conducted every other year. The NLSY-Child collects information on more than 11,000 children regarding developmental assessment, family background, home environment and health history. The researchers assessed data on 1,797 children who were approximately six years of age at the time of one of the four most recent survey interviews in 1994, 1996, 1998 and 2000. Scores in mathematics, reading recognition and reading comprehension from a commonly used and well-standardized test were compared with the level of television watching before age three and from ages three to five.

"This analysis has shown a consistent pattern of negative associations between television viewing before age three years and adverse cognitive outcomes at ages six and seven years," the authors report. "The inclusion of extensive controls for parental preferences, ability, and investment in their children's cognitive development suggests that these associations may in some direct or indirect way be causal."

"By contrast, this analysis suggests that television viewing at ages three to five years has a more beneficial effect, at least for the outcomes of reading recognition and short-term memory," the authors write. The researchers found no beneficial effect on mathematics outcomes or reading comprehension, and they state, "Because reading recognition and short-term memory are arguably the most basic of the cognitive outcomes studied, the implication would seem to be that the net effect of television viewing from a population perspective is limited in its beneficial impact."

"One of the contributions of this study is to recognize and explicitly model the heterogeneous [mixed] effect of television viewing at different ages on children's outcomes," the authors write. "Television viewing in early childhood varies depending on age; for very young children the effects are negative, while for preschool children they can be constructive, at least in some domains. This analysis further suggests that parents may appreciate and benefit from better guidance on the kinds of high-quality content that is available on television and on ways of managing the context of television viewing to maximize its potential benefit for their children."

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